This prospective, multicenter cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization techniques for breast duct lesions. The principal objective is to assess the clinical efficacy of this innovative fluorescent localization needle in enabling precise pathological diagnosis of micro lesions in breast ducts.
Female patients aged 18-75 years.
Patients scheduled to undergo duct excision surgery.
Patients who are capable of providing written informed consent and adhering to the study protocols.
Pregnant or breastfeeding.
Patients who have known allergy to quantum-dot materials or localization needle components.
Patients with active hepatitis B or C infection with detectable viral load.
Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).
Parallel
novel fluorescent localization marker needle
Devicenovel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating
conventional localization marker needle
Deviceconventional localization marker needle, without any coating
pathological assessment concordance rates
Evaluate and compare the discrepancies in the consistency of intraoperative frozen and postoperative paraffin-embedded pathological assessments between subjects undergoing breast duct excision surgery utilizing a novel fluorescent localization marker needle and those employing conventional localization methods.
Click on the lead sponsor to view all of their trials.
